Protagonist Therapeutics (NASDAQ:PTGX) executives said March 18 that the U.S. Food and Drug Administration has approved ICOTYDE for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kilograms and are candidates for systemic therapy or phototherapy.
On the company’s conference call, President and CEO Dr. Dinesh Patel called the approval a “major milestone” for Protagonist and congratulated Johnson & Johnson, which will handle commercialization. The company emphasized that ICOTYDE is an oral peptide therapy that blocks the IL-23 pathway by targeting the IL-23 receptor, which Patel contrasted with injectable antibodies that target the IL-23 ligand.
Clinical program and label breadth
Management also highlighted factors it said contributed to a broad label, including:
- Studies in both adults and adolescents.
- Evaluation in “high-impact disease sites.”
- Two head-to-head studies showing superiority to the active comparator Sotyktu, as discussed on the call.
In the Q&A, executives noted investor discussion around potential testing requirements and described the label as “really clean” with respect to specific testing requirements. Protagonist did not provide detailed commentary on label negotiations, noting that Johnson & Johnson led discussions with the FDA.
Expansion beyond psoriasis and “pipeline in a product” framing
Protagonist said it is encouraged by ongoing studies evaluating ICOTYDE in additional indications beyond psoriasis. Patel pointed to historical outcomes for IL-23 pathway-blocking injectable antibodies—Stelara, Skyrizi, and Tremfya—saying they have been successful across psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease. He cautioned, however, that ongoing studies will determine the opportunity “more precisely over the coming years.”
Patel said the total development effort across the approved psoriasis program and ongoing studies exceeds 7,000 patients, and he described ICOTYDE as “a pipeline in a product” and a potential multi-indication immunology franchise.
Economics with Johnson & Johnson and patent comments
On the financial impact, Patel said the approval triggers an immediate $50 million milestone payment and begins a royalty-based revenue stream. He also stated that since the start of the Johnson & Johnson collaboration in 2017, Protagonist has earned $387 million in milestone payments and still has “around $580 million” in potential future milestones.
Management further outlined the royalty terms discussed on the call, including tiered royalties ranging from 6% to 10% on global net sales and a weighted average of 7.25% at $4 billion in annual sales, rising to 10% for sales above $4 billion. The company declined to comment on pricing, gross-to-net assumptions, payer dynamics, or launch specifics, repeatedly noting those are Johnson & Johnson topics.
Asked about patent protection, Patel said Protagonist is “very pleased” with the extent of protection and described it in broad terms as extending to “2040 or slightly behind that.”
Pipeline updates: rusfertide, IL-17, obesity programs, and capital allocation
Beyond ICOTYDE, Patel said the company expects an FDA decision in the third quarter of the year for rusfertide, a first-in-class hepcidin mimetic for polycythemia vera partnered with Takeda. He said the NDA was filed on Dec. 29 of the prior year and that the FDA granted priority review earlier in the month.
Patel also said Protagonist is “strongly leaning” toward opting out of its co-development and co-commercialization arrangement with Takeda, which he said would qualify the company for a $400 million opt-out payment and shift economics from a 50/50 profit-and-loss split to an out-licensing model with enhanced milestones and royalty-based economics.
In earlier-stage programs, Protagonist highlighted PN881, an oral IL-17 peptide antagonist with activity against IL-17A and IL-17F, currently in a Phase 1 study expected to complete by mid-year, with next-step guidance anticipated in the third quarter. The company also discussed PN8047, an oral hepcidin functional mimetic in IND-enabling studies, noting it is a small molecule rather than a peptide. In obesity, Patel said PN477 is an oral triple GLP/GIP/GCG agonist being developed as both a weekly injectable and a once-daily oral agent, with Phase 1 studies expected to start in the second half of the year.
On capital allocation, Patel said the company is considering ways to return capital to shareholders, including share buybacks, but indicated additional visibility would come later in the year as events such as a rusfertide decision and a potential Takeda opt-out play out.
About Protagonist Therapeutics (NASDAQ:PTGX)
Protagonist Therapeutics, Inc (NASDAQ: PTGX) is a clinical-stage biopharmaceutical company focused on the development of novel, orally administered peptide-based therapies for immune-mediated and other serious diseases. The company leverages its proprietary Peptide 2.0 platform to design peptides that target G protein–coupled receptors and cytokine receptors, with the goal of combining the potency of biologics with the convenience of oral administration. Protagonist’s approach aims to address unmet medical needs in areas where injectable therapies have been the standard of care.
Among its lead programs is PTG-100, an oral α4β7 integrin antagonist intended to block leukocyte migration to the gut in ulcerative colitis and Crohn’s disease.
